Are fertility tracking apps regulated?
Fertility tracking apps are widely used, but are they regulated as medical devices? The answer depends on functionality. Some apps that support conception or contraception fall under UK and EU medical device regulations, while others remain outside formal oversight. Understanding when fertility apps are regulated is essential for both users and developers navigating safety, data protection, and compliance.
Functionality of applications to support fertility range from simple cycle diaries to complex algorithms claiming to deliver effective contraception. At what point does a fertility app become a regulated medical device?
There’s been a growing wave of fertility-related apps on the market since the early 2010s, with the first regulated fertility app certified in the latter half of the decade. Recent high profile cases, such as Flo Health settling a class action lawsuit in the US over claims the company shared user’s fertility-related health information with third parties, have raised questions over whether users are aware if the fertility app they are using is (or should be) regulated as a medical device and what laws are in place to protect their data.
What are fertility tracking apps?
Fertility tracking apps range from basic cycle logging and provision of generic information to products claiming to provide personalised recommendations, effective contraception and supporting pregnancy planning. For example, Natural Cycles is described by its Swedish manufacturer as “a stand-alone software application, intended for women 18 years and older, to monitor their fertility… which can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).” This kind of app often incorporates routinely collected, user-entered basal body temperature measurements and other health data to inform users of their live fertility status.
Is fertility tracking mentioned in the medical device regulations?
Both the UK and EU regulations state that any device (including software) used for the “control of conception” is a regulated medical device. So the short answer is yes. However, as with many software products there are grey areas in the regulatory framework which impact the qualification and classification of different software products operating in the fertility space.
The Borderline Manual is a guidance document describing regulatory edge cases with a rationale for medical device qualification and classification, primarily based on the current UK regulatory framework (EU MDD). It provides some examples to delineate the classification of different fertility apps, namely:
Where a product intended to facilitate conception based on basal body temperature it is considered a Class I medical device.
However, a product intended to prevent pregnancy falls into Class IIb, due to a special classification rule in the regulations (EU MDR Rule 15, which is the equivalent of Rule 14 in the EU MDD).
EU MDR Rule 15
As with any contraceptive, users could rely on outputs from the app’s algorithm to avoid pregnancy with inaccurate data potentially leading to unintended pregnancy and resulting in significant physical and psychological harm.
Users should be aware that uncertified fertility apps could still be available to consumers. For example, apps which are limited to storage or display of manually entered user data, like a simple cycle diary, may not qualify as a medical device. On the other hand, manufacturers attempting to avoid regulators by operating in a grey area or inappropriately marketing themselves as “wellness” products may not have appropriate regulatory oversight. It’s important to note that such products will not have undergone the same level of clinical validation or technical and cybersecurity testing that is required of medical devices.
Regardless of medical device status or claims, apps collecting personal health information, including simple cycle diaries, are still subject to general data protection regulations (GDPR). Users should be wary of “wellness” apps claiming to support conception or contraception and should always check medical device status where possible, and consult healthcare professionals and established information sources when exploring alternative fertility options.
The future of fertility app regulation
In 2021, the EU MDR introduced stricter classification rules for software devices on the European Union market. With planned updates to the UK medical device regulations expected to align more closely to the EU MDR, we may see a strengthening in the regulation of digital health products on the GB market, including fertility apps.
Steps are also being taken to increase the transparency of the sector, with the MHRA recently updating their public database to include product names, which should make it easier for users and clinicians to verify the registration status of fertility tracking apps.
The Femtech sector is growing rapidly and there is mounting pressure to ensure regulation and evaluation of women’s health tech products is appropriately robust and does not fall into the historic pitfalls of the pharmaceutical industry.
If you’re a fertility app developer, reach out for support with determining medical device status and getting compliant to ensure the safety of your users.
